Comparison of efficacy of ipraglifrozine and high-dose metformin in patients with type 2 diabetes

Comparison of efficacy of ipraglifrozine and high-dose metformin in patients with type 2 diabetes - COLOR stduy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014963

Enrollment

144

Registered

2014-08-30

Start date

2014-09-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

In patients with type 2 diabetes currently receiving metformin 500 or 750 mg/day, the dose will be doubled and the patients will be observed for 52 weeks. In patients with type 2 diabetes currently re

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >=0 and <75 years at the time of consent 2. HbA1c 6.5-10.0% (NGSP) at the time of consent, with no change in oral medications during the preceding 3 months 3. Patients with type 2 diabetes previously treated with diet and exercise plus 500-750 mg of metformin hydrochloride, or with additional oral hypoglycemic agents other than SGLT2 inhibitors as monotherapy or in combination 4. Patients whose blood pressure and lipid control are stable and for whom addition of new agents during the study period is not anticipated 5. Written informed consent obtained after sufficient explanation and understanding, based on the patient's free will

Exclusion criteria

Exclusion criteria: 1. Patients treated with insulin 2. Patients whose diabetic retinopathy is not stable 3. Patients for whom participation is difficult due to severe hepatic, renal, cardiac, or respiratory disease (specifically: liver function >=2.5x upper limit of normal; renal function: serum creatinine >=1.3 mg/dL in men or >=1.2 mg/dL in women, or eGFR <30 mL/min/1.73 m2; or decreased cardiac/respiratory function) 4. Patients with a history of hypersensitivity to components of the study drugs 5. Pregnant or lactating women, or women who may be pregnant 6. Patients with severe ketosis, diabetic coma or pre-coma 7. Patients with severe infections, perioperative status, or serious trauma 8. Any other case judged by the principal or co-investigator to be unsuitable as a subject

Design outcomes

Primary

Measure	Time frame
The between-group difference in mean HbA1c change from baseline to week 52.	—

Secondary

Measure	Time frame
Body composition, metabolic biomarkers, adipokines, and safety outcomes, as well as subgroup analysis of HbA1c change by baseline HbA1c (<8.5% vs >=8.5%).	—

Countries

Japan

Contacts

Public ContactTaku Watanabe

Hokkaido University Hospital First Department of Medicine

takuwatanabe-circ@umin.ac.jp011-706-5911

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026